U.S. patent number 9,005,250 [Application Number 12/917,912] was granted by the patent office on 2015-04-14 for system and devices for the repair of a vertebral disc defect.
This patent grant is currently assigned to Kensey Nash Corporation. The grantee listed for this patent is Douglas G. Evans. Invention is credited to Douglas G. Evans.
United States Patent |
9,005,250 |
Evans |
April 14, 2015 |
System and devices for the repair of a vertebral disc defect
Abstract
A method of supporting a defect in the tissue of a living being
includes the steps of: a) providing a delivery instrument that
includes an elongated instrument, at least one barrier element, and
a plurality of connecting members; b) inserting the elongated
instrument into the tissue at or near the defect; c) deploying the
barrier element from the delivery instrument into tissue at or near
the defect, the barrier element having at least one connecting
member attached thereto; d) extending at least one passage means
from the delivery instrument; e) engaging at least a portion of the
at least one connecting member with the at least one passage means,
whereby the at least one passage means causes the at least one
connecting member to pass through the tissue, and f) withdrawing
the elongated instrument from the tissue, thereby deploying and
securing the barrier element to support the tissue.
Inventors: |
Evans; Douglas G. (Downingtown,
PA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Evans; Douglas G. |
Downingtown |
PA |
US |
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|
Assignee: |
Kensey Nash Corporation (Exton,
PA)
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Family
ID: |
37768178 |
Appl.
No.: |
12/917,912 |
Filed: |
November 2, 2010 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20110046649 A1 |
Feb 24, 2011 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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11187064 |
Jul 22, 2005 |
7824414 |
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Current U.S.
Class: |
606/279;
623/17.11; 606/151; 606/77; 606/99; 606/328 |
Current CPC
Class: |
A61F
2/442 (20130101); A61F 2/4611 (20130101); A61F
2002/4627 (20130101); A61F 2310/00011 (20130101); A61F
2210/0004 (20130101); A61F 2002/30062 (20130101); A61F
2002/30841 (20130101); A61F 2310/00365 (20130101); A61F
2002/30179 (20130101); A61F 2230/0058 (20130101); A61F
2002/30579 (20130101); A61F 2002/4435 (20130101); A61F
2002/30075 (20130101); A61F 2002/30235 (20130101); A61F
2230/0069 (20130101); A61F 2210/0061 (20130101); A61F
2002/3092 (20130101); A61F 2002/4495 (20130101) |
Current International
Class: |
A61B
17/88 (20060101) |
Field of
Search: |
;606/279,151,328,77,99
;623/17.11 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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WO0195818 |
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Dec 2001 |
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WO |
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WO2005020859 |
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Oct 2005 |
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WO |
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Primary Examiner: Hammond; Ellen C
Attorney, Agent or Firm: Ramberg; Jeffrey R.
Parent Case Text
RELATED APPLICATION
This application is a Continuation of U.S. application Ser. No.
11/187,064, filed on Jul. 22, 2005, now U.S. Pat. No. 7,824,414,
which is assigned to the same assignee as this invention, and whose
disclosure is incorporated by reference herein.
Claims
What is claimed is:
1. A method of supporting a defect in the tissue of a living being
comprising the steps of: a) providing a delivery instrument
comprising an elongated instrument, at least one barrier element,
and a plurality of connecting members; b) inserting said elongated
instrument into the tissue at or near the defect; c) deploying said
barrier element from said delivery instrument into tissue at or
near the defect, said barrier element having at least one
connecting member attached thereto; d) extending at least one
passage means from said delivery instrument; e) engaging at least a
portion of said at least one connecting member with said at least
one passage means, whereby said at least one passage means causes
said at least one connecting member to pass through the tissue
adjacent the defect, and f) withdrawing said elongated instrument
from the tissue, thereby deploying and securing said barrier
element to support the tissue.
2. The method of claim 1, wherein the method further comprises the
additional step of: g) positioning at least one fastening element
about said connecting members, said fastening element being
arranged to maintain tension upon said connecting members.
3. The method of claim 1, wherein at least one of said at least one
barrier element and said plurality of connecting members are
resorbable.
4. The method of claim 1, further comprising delivering at least
one medication at a site of said inserting and to surrounding
tissue by coating at least one fastener component with said
medication.
5. The method of claim 1, wherein the tissue defect is in the
annulus fibrosis of a vertebral disc, said method further
comprising positioning an access cannula through the defect.
6. The method of claim 5, wherein said access cannula initially
houses an obturator, and said obturator is removed once said access
cannula is positioned.
7. The method of claim 5, further comprising introducing a
guidewire or wire-like element into said access cannula.
8. The method of claim 7, further comprising guiding said access
cannula over said wire-like element to a site of said
inserting.
9. The method of claim 8, further comprising introducing a tissue
dilator into said access cannula, and expanding a size of the
defect with said tissue dilator.
10. The method of claim 5, further comprising monitoring a position
of said device.
11. The method of claim 10, wherein location detection is provided
by a locking mechanism, said method further comprising deploying
said locking mechanism.
12. The method of claim 11, wherein said locking mechanism is
deployed by actuating an actuation mechanism.
13. The method of claim 12, wherein said actuation mechanism is
activated by at least one of mechanical actuation and inflation
with an inflation charge.
14. The method of claim 10, further comprising retracting said
access cannula until a desired location is achieved.
15. The method of claim 10, further comprising advancing a locking
mechanism down the access cannula.
16. The method of claim 15, wherein said locking mechanism is
placed against the skin of the living being.
17. The method of claim 5, wherein said delivery instrument is
delivered to the living being through said access cannula.
18. The method of claim 5, further comprising (i) deploying at
least two positioning elements from said delivery instrument,
whereby said positioning elements extend laterally from said
delivery instrument, and (ii) withdrawing said access cannula and
delivery instrument as a unit until the deployed positioning
elements contact the interface between the annulus and the
nucleus.
19. The method of claim 1, further comprising at least one
intermediate component associated with at least one of said
connecting members.
20. The method of claim 19, wherein said intermediate component
comprises at least one sealing member.
21. The method of claim 19, wherein said intermediate component
comprises a polymer.
22. The method of claim 19, wherein said intermediate component is
resorbable.
23. The method of claim 19, wherein said intermediate component
contains at least one bioactive substance.
24. The method of claim 19, wherein said intermediate component
contains at least one drug.
25. The method of claim 1, further comprising deploying at least
two positioning elements from said delivery instrument, to position
at least a portion of said connecting members to a location where
said passage means can cause said connecting members to pass
through the tissue.
Description
FIELD OF THE INVENTION
The invention relates generally to methods and devices for human
surgery, and in particular these methods and devices may be useful
for spinal surgery. More particularly, certain embodiments of the
invention relate to devices and methods for treating injuries,
defects or surgical procedures associated with the intervertebral
disc.
BACKGROUND OF THE INVENTION
Injuries to the human spine and subsequent pain are one of the most
prevalent debilitating conditions affecting the human population.
For many of those affected, no position can ease the pain or
discomfort associated with spinal injuries or deformities. Such
spine related pain can lead to decreased productivity due to loss
of work hours, addiction to pain-killing drugs, emotional distress,
and prolonged hospital stays. The economic impact of such problems
is significant. One common cause for many instances of chronic pain
is the bulging, or herniation of the intervertebral disc.
The intervertebral disc is made of two parts, a tough collagen
outer layer, known as the annulus fibrosus (hereinafter also
referred to as "AF" or "annulus"), and a soft central core known as
the nucleus pulposus (hereinafter also referred to as "NP" or
"nucleus"). The annulus is composed of numerous concentric rings or
layers of fibrocartilaginous tissue. Fibers in each ring cross
diagonally, and the rings attach to each other with additional
radial fibers. The rings are thicker anteriorly (ventrally) than
posteriorly (dorsally). The nucleus is a gelatinous material, which
forms the center of the disc. The discs tend to vary in size and
shape with their position in the spine. The nucleus is composed of
a loose, nonoriented, collagen fibril framework supporting a
network of cells resembling fibrocytes and chondrocytes. This
entire structure is embedded in a gelatinous matrix of various
glucosaminoglycans, water, and salts. This material is usually
under considerable pressure and is restrained by the annulus.
A tear or weakening in the layers of the annulus fibrosus portion
of the disc can allow the soft center portion of the disc (the
nucleus) to leak out of the annulus, alternatively, the weakened
annulus may simply bulge. A ruptured disc may allow the leaking
nucleus pulposus material to press up against a spinal nerve root
or spinal cord, causing pain, numbness, tingling and/or weakness in
a person's extremities. Herniated discs may occur at any level of
the spine, but are more common in the lumbar area, followed in
frequency of occurrence by the thoracic region and cervical region.
Weakening or tearing of the annulus fibrosus may also result in
bulging of the annulus fibrosus due to pressure of the nucleus
pulposus against the annulus. The bulging tissue may also impinge
upon the nerve root or spinal column, causing pain.
The traditional surgical method for treating a damaged, bulging, or
herniated disc involves tissue removing procedures to relieve the
impingement of the annulus fibrosus or the nucleus pulposus from
the surrounding nerves. The procedure is commonly known as a
discectomy, and consists of the removal of at least a portion of
the disc; it may be performed in an open procedure, a minimally
invasive procedure, or an endoscopically assisted procedure. These
procedures generally result in a large defect of the annulus
fibrosus and in a certain percentage of cases, may lead to
progressive degradation of the disc, both nucleus pulposus and
annulus fibrosus, listhesis of adjacent vertebral bodies, stenosis
of the nerve canals and increases in related pain symptoms. A means
of mechanically and/or biologically repairing the annulus fibrosus
may delay or prevent this degeneration cascade of the disc.
Newer technologies and procedures, such as nucleus replacement with
injectable or solid prosthetic nucleus devices may also result in a
breach in the otherwise coherent annulus fibrosis. In these cases,
it is desirable to mechanically close, or otherwise repair the
defect in the annulus created to insert the prosthetic material and
prevent such material from leakage and extravasation.
The annulus fibrosis (AF) of the intervertebral spinal disc is a
lamellar configuration of collagen layers intended to maintain the
soft viscous internal nucleus pulposus (NP), provide for motion and
linkage of the adjacent vertebral bodies (VB). Certain degenerative
or pathologic changes may occur either within the NP which can lead
to over stress of the AF and subsequent damage to or tearing of the
AF. If left untreated, herniation of the NP may occur, most
importantly, the herniation may progress posteriorly toward the
spinal cord and major nerve roots. The most common resulting
symptoms are pain radiating along a compressed nerve and low back
pain, both of which can be crippling for the patient. The AF may
also be torn through traumatic injury, which can lead to
progressive degenerative changes and herniation or ultimately
listhesis of the adjacent VB, degenerative changes in the lumbar
spine that may result in a loss of spinal stability and subluxation
of one vertebra relative to another.
Herniation may be caused by, or be the result of weakening in the
AF. Secondary to physiologic changes of the AF or NP, the AF may
weaken and protrude from its normal anatomic space, similar to an
air bubble bulge in a car tire, or in more severe cases, the AF may
tear and allow extravasation of the NP contents to the surrounding
anatomy. Symptoms may arise when the herniation or leakage of the
NP impinges on the nerve root or spinal cord. There are therapies
currently utilized for treatment of the herniation of a vertebral
disc, and the resultant pain, starting with conservative therapies
such as bed rest and pain medicines, to more invasive therapies,
such as epidural injections, open or minimally invasive
discectomies or aggressive therapies, such as complete discectomy
and fusion of the disc space and adjacent vertebrae.
The prior art describes various procedures and devices for
repairing damage to the vertebral disc. The prior art describes
repairing a herniated disk by various means, including prosthetic
implants, and stressed members. For example, in U.S. Pat. No.
6,805,695, Keith et al. disclose devices and methods of reinforcing
an annulus of the disc by introducing a circumferential
reinforcement member around the annulus of the disc, or through the
annulus and nucleus of the disc.
In U.S. Pat. No. 6,371,990, Ferree discloses an apparatus and
method for repairing annular tears and the prevention of further
annular tears. Ferree seeks to control vertebral motion by
augmenting the annulus with an implant, thereby minimizing the
opportunity for annular tears. The augmenting implant is described
as being a mesh that may be stapled into the interior of the
annulus.
Ferree also discloses in U.S. Patent Application 2004/0097980 an
expandable material to fill a defect in a disk, and that the
material may be anchored to the annulus with respect to the void
filled. In an embodiment, the anchors are described as penetrating
through the outer wall of the disc and serve to hold the flexible
implant material in place.
Yeung discloses in U.S. Pat. No. 6,530,933 a method and apparatus
for herniated disc repair using resilient fastener elements that
are implanted and spring back to an original shape to apply tension
through gripping elements to hold tightly to the annulus. In an
alternative embodiment, the annulus repair technique utilizes a
suture affixed to a dumbbell shaped rod to serve as an anchor. The
anchor is placed against the outside surface of the annulus, and
the suture extends across the interior of the vertebral disc
through the nucleus pulposus and out the other side of the disk,
such that tension may placed against the disc to repair the hernia,
and the tension may be maintained through the use of a washer and
suture locking element, such as a knot. With this alternative
embodiment, a sealing material may optionally be placed underneath
the washer.
In U.S. Pat. No. 6,592,625, Cauthen describes annular repair or
reconstruction by insertion of a collapsible patch into the
subannular space, whereupon the patch expands to fill the gap and
seal off the opening from the escape of nucleus material. Cauthen
describes his device as being useful to restore integrity after
damage or discectomy to alleviate a herniated vertebral disc;
Cauthen does not obviate the need for the discectomy procedure to
repair a herniated disc.
In U.S. Pat. No. 6,224,630, Bao describes the repair of an
intervertebral disc using an expandable porous material that is
inserted into an aperture, and subsequently becomes more
permanently secured as the ingrowth of tissue into the pores is
actively facilitated. Bao creates a device having a tamponade
effect where the swelling of the material provides securement and
does not describe a more secure mechanical anchorage using a rigid
component in combination with a tissue regenerative material.
The prior art also describes various methods for sealing a
percutaneous closure, for example, Kensey et al. in U.S. Pat. No.
5,545,178 describe a system for sealing a puncture made through
skin and having a tract extending through to underlying tissue. The
puncture closure system consists of an anchor introduced into the
underlying tissue and having a filament attached thereto, the
filament extends out from the puncture, and facilitates the
introduction of a plug material into the tract, whereupon tension
is maintained through the use of a holding member. Kensey et al.
does not describe the sealing of multiple sites through the
employment of a single device, nor is the employment of multiple
anchors or plugs on a single filament described.
In U.S. Pat. No. 6,136,010, Modesitt et al. describe a system for
suturing vascular puncture sites located at the distal end of a
percutaneous tissue tract. The system consists of a suture
introduced into the tissue surrounding the puncture. Said system is
not suitable for closing defects in the annulus as it relies on the
ability to re-approximate tissues around a defect in order to close
the opening and prevent tissue from exiting through the
puncture.
In U.S. Pat. No. 5,728,114, Evans et al. describe an apparatus for
reducing bleeding from a percutaneous arterial puncture. The
apparatus comprises a mass of material for inhibiting blood flow, a
suture, and means for holding the material at the desired site. For
reasons that will become apparent later, said system is not optimal
for closing defects in the annulus as it is better suited to
deliver a material to the outside of a tissue defect.
The prior art does not describe a device wherein the device may be
capable of being implanted arthroscopically, among other methods
known in the art, and is arranged to prevent the escape of nucleus
pulposus from a defect in the annulus, while providing support to
the defect, securement, and effective sealing means in a single
device.
Accordingly, there is a need for a system or device that is capable
of meeting these and other objectives, wherein the system provides
means for minimally invasive delivery of a device that provides
tissue support, incorporates a barrier element to assist with
defect closure, a secure sealing means for positioning at the
defect, securement means for holding the device in place, as well
as the ability to provide for cellular infiltration and subsequent
repair occurring in or around the annulus fibrosis. Furthermore,
there is a need for a device capable of preserving or restoring
normal annulus geometry (e.g., repairing a herniated disc), wherein
there is support and secured sealing provided at each point of
penetration or defect in the annulus.
It is the intent of the present invention to overcome these and
other shortcomings of the prior art.
SUMMARY OF THE INVENTION
Various embodiments of the current invention strive to overcome
these various shortcomings in the prior art. These embodiments
allow for singular devices, or combinations of barriers, anchors or
fastening devices which prevent the escape of nucleus material or
nucleus replacement and/or other therapeutic materials while
providing support to the annulus, sealing elements, securement
elements, as well as components for restoring or maintaining
satisfactory disc geometry and providing the scaffold for
regeneration of the damaged annulus and other tissues.
Certain of these embodiments have barriers and or anchors (e.g.
membranes, plates, fabrics, meshes, anchors, etc.), which may be
deployed in a manner associated with one or both sides of the
annulus wall. The barrier member, or barrier means, serves to
bridge any gap between the opposing edges of the opening or defect.
Once the barrier is secured adjacent to the defect, it serves to
prevent tissues, such as nucleus material, from migrating through
the defect. The barrier may also be suitable for helping to contain
nucleus replacement materials within the nucleus portion of the
annulus. In some instances, the opening in the annulus will be such
that the edges of the defect can be drawn together with the
filament portion of this invention. In this instance, the barrier
provides reinforcement or support to the tissue at the defect site.
In some embodiments, securement of the barrier to the defect site
will thereby create and exert pressure on the annulus wall. This
pressure alone may serve to support and/or seal the annulus. In
some embodiments, combinations of barriers are used at multiple
locations with respect to the annulus. The barriers themselves may
feature or further be utilized in combination with a sealing means
(e.g., elastic biomaterials, patches, collagen, adhesive, thrombin,
hydrogel, etc.) that may be beneficial or necessary to aid sealing.
The various embodiments of the invention contemplate the use of a
variety of devices including, but not limited to patches, plugs,
staples, expandable materials, meshes, anchors, sutures, flowable
materials, sealants, glues, gels and other wound and tissue repair
devices known in the art. To that end, a barrier member may be
rigid, compliant, or elastic; furthermore, the barrier member may
be a composite of various materials, which are, separately or
together, best suited for support and/or sealing functions. Such
components may comprise materials inherently radiopaque or they may
be treated with substances which make them radiopaque when viewed
under any imaging techniques utilized by the surgeon to visualize
placement.
Several embodiments of the present disclosure utilize connecting
means. The connecting means, connecting member, or connecting
element, as the terms may be used interchangeably herein, may be
comprised of a number of elements known in, or common to, the art
including but not limited to filaments, suture, fabric, threads,
ribbon, wire, etc. In a preferred embodiment, the system may be
adapted for various types of deployment, such as, portion of the
connecting means may be positioned through the tissue that is
adjacent to the defect or opening in the annulus. A novel aspect of
some embodiments of this invention is a delivery system that has
the ability to deliver connecting means through the tissue adjacent
to the defect. In some embodiments, a portion of the filament or
connecting means may be positioned to extend through the defect or
opening in the annulus. In some instances, a portion of the
connecting means is intended for passage through the same puncture
through which the delivery instruments access the annulus and
nucleus tissues. In general, the connecting means can be used in
conjunction with one or more of the barrier, sealing, or securement
means to aid in the closure and or repair of the defect.
Several embodiments of the present disclosure utilize at least one
sealing means. The sealing means, or sealing member, as the terms
are used interchangeably herein, may be most beneficial if placed
at the outside of the wall of the annulus, though it may also be
placed within the wall of the annulus, depending on the geometry of
the device, the type of sealing means, and the geometry of the
affected anatomy. That being said, the sealing means can be
positioned in a number of locations depending on the defect being
treated. For example, it may be desirable to have some portion of
the sealing means extend into the wall of the annulus and
potentially into the NP. Furthermore, the seal may be placed
proximal or distal to the fastening device(s). It is recognized
that the force internal to the annulus (i.e., the force from the
fluid nucleus pulposus) may assist sealing by pressing the sealing
means against the annulus, where such sealing means may be
preferably located internal to the annulus. The sealing means may
be used as a scaffold to help with the repair of the defect. The
sealing means may serve as a tissue regeneration guide and may also
serve to deliver appropriate agents to the tissue defect.
Several embodiments of the present disclosure utilize at least one
securement means, or securement member, as the terms are used
interchangeably herein. The securement means may be used in some
embodiments to secure the filament and or barrier element at the
defect site. The securement means can be stored within the
instrument of the invention or added to the device externally and
positioned at a location suitable to secure the device. For
example, a surgeon can form a knot on the filament portions of
several embodiments of this invention and slide the knot adjacent
to the tissue defect to secure the device in position. The various
embodiments of the invention contemplate the use of a securement
means including devices capable of maintaining tension placed on
the connecting means or maintaining the desired positions of the
device components, including, but not limited to, locking
components, knots, plugs, staples, locking washers, slidable
components, deformable elements, expandable materials, sealants,
glues, gels and other devices known in or common to the art.
Overall disc or annulus geometry may be beneficially altered by
placing a device at or through a distal wall of the annulus, while
placing a second device at or through the proximal wall, where the
devices are connected, e.g., by a tether, suture, flexible, or
rigid member. This type of device would allow compression to be
placed across each disc wall, while simultaneously compressing or
restraining the disc across its diameter. Again, sealing means may
be employed, as previously discussed.
These various embodiments may be particularly useful in the
situation where the annulus is torn. Since the annulus is fibrous,
tears generally occur in the circumferential direction (i.e., not
purely radial) along at least a portion of the fibers. Deploying a
device across the tear could cause compression to be placed across
the torn annulus surfaces, thereby allowing the combination of
securement and friction (thereby restricting movement of the torn
surfaces against each other) to hold and support the annulus.
Commonly, discectomies or laminectomies are performed to relieve
pain. These embodiments may augment, if not replace these types of
procedures. That is, multiple fasteners, or a single through-wall
fastener, may be placed proximal and distal to the annulus entry
tract (in the case of a discectomy), and a sealing patch may be
placed adjacent either fastener, or the sealing patch may reside
mid-wall to the annulus.
It is also recognized that a sealing member may function as a
fastener itself, thereby minimizing the number of device
components, procedural steps, and/or procedural time. To that end,
a sealing member may be rigid, compliant, or elastic; furthermore,
the sealing member may be a composite of various materials, which
are best suited for support and sealing functions. As a
non-limiting example, such fasteners may be comprised of a rigid
polymeric backing material (which may or may not be resorbable,
e.g., PLA or polyurethane) which has a layer that contacts the
tissue which comprises a malleable material, which may or may not
be resorbable (e.g. polymer, collagen, etc.) to seal the tear or
procedurally made opening. Such components may be comprised of
materials inherently radiopaque or treated with substances which
make them radiopaque when viewed under standard imaging techniques
to allow the surgeon to visualize placement.
These various embodiments may be at least partially made from
permanent or biodegradable materials such as those listed in Table
1, and these devices may have a secondary or tertiary effect by the
delivery of drugs or biologics such as those listed in Table 2. In
an embodiment of a fastening or sealing device made from the
materials described above, once implanted in a living being, the
device may cause or induce the new growth or regrowth of cellular
material. In this embodiment, the material encourages the ingrowth
of cellular material that securely integrates the device into the
surrounding tissues, thereby repairing the weakened area in a more
effective manner.
In the embodiment where the device is a resorbable material, the
ingrowth of cellular material into the device allows for a
permanent repair upon complete resorption of the resorbable device,
as the material is replaced by the growth of cells to create a
natural tissue material similar to and integrated with the
surrounding structures.
In the embodiment where the device is a non-resorbable material,
the ingrowth of cellular material into the device allows the
complete integration of the device with the surrounding tissue,
thereby creating a suitable repair having nearly similar compliance
and other physical characteristics as the original tissue
material.
Several embodiments of the present disclosure utilize at least one
elongated delivery means, instrument, or member, as the terms are
used interchangeably herein. The elongated delivery means may be
used in some embodiments to position or deposit the device
components (e.g. barrier, filament, securement element, sealing
means, etc.) at a desired location with respect to the defect site.
The elongated instrument is suitable for being arranged through the
defect or an opening at a location to repair the defect or
opening.
In yet another embodiment, the treatment device comprises an
elongated instrument, at least one bridging member, and a plurality
of connector members. The elongated instrument may be placed in or
near the defect, where it is used to deliver the at least one
bridging member inside of the intervertebral disc. The elongated
instrument may then displace the bridging member from the deployed
position, to a position against the inside wall of the disc. This
placement should cover at least a portion of the defect.
Additionally, the connector members may be deployed from the
elongated instrument into tissue at or near the defect and thereby
engage the at least one bridging member such that the bridging
member is secured against the wall of the disc. This embodiment
will afford support to the defect area of the disc.
This embodiment is envisioned to be operative with various other
embodiments in the present disclosure. For example, the device may
additionally include a fastening element, wherein the fastening
element acts cooperatively with the connecting means to secure the
bridging element against the disc. Various or all of the members
and components of this embodiment may be resorbable, and located or
positioned as described elsewhere herein, or by methods known to
those in the art.
In certain embodiments the delivery instrument may feature at least
one passage element, which may be capable of providing a means for
directing or passing at least one connecting member through tissue
adjacent to the defect site. A portion of the passage element,
passage member, or passage means (e.g. needle), in some
embodiments, can be made to temporarily extend from a portion of
the elongated delivery instrument into the adjacent tissue for the
purposes of passing a portion of the connecting element into the
tissue. Preferably, the passage element can then retract into the
elongated delivery instrument prior to device removal.
In some embodiments the delivery instrument comprises means for
positioning the connecting element(s) into a position for optimal
passage through the tissue adjacent to the defect site. The
positioning means, positioning member, or at least one positioning
element, in some embodiments, can temporarily extend axially from a
portion of the elongated instrument, (e.g., into the adjacent
tissue) for the purposes of cooperating with the passage element in
order to position a portion of a connecting element into and or
through the tissue adjacent to the defect. Preferably, the
positioning means can be retracted into the elongated delivery
instrument prior to device removal.
Procedurally, these various embodiments may be delivered from
posterior or anterior directions, based on the anatomical
constraints as well as, among other things, herniation, disease, or
type and geometry of the defect. While it is envisioned that
similar, if not the same, delivery devices and methods may work for
posterior as well as anterior procedures and placements, certain
types of procedures may benefit greatly from devices or embodiments
which sense their location or detect where they are located in the
anatomy. For many annulus repair devices it may be beneficial to
utilize minimally invasive methodologies to position the device.
Minimally invasive procedures utilize laproscopic or endoscopic
instruments to perform procedures through small openings in a
patient's skin and can result in less trauma and faster healing
times for the patient. However, such approaches are challenging in
that the physician may not be able to directly visualize many
aspects of the procedure. It has been discovered through
experimentation in ex-vivo models that several embodiments of the
devices of this invention can benefit by using delivery systems
that can locate the transition between the annulus and the adjacent
tissues to ensure proper device placement.
Location detection devices are known in the art, for example U.S.
Pat. No. 5,282,827, assigned to the assignee of the present
disclosure, may be used to accurately place a hemostasis device in
an artery (delivery of a hemostasis device using a location
detector) also assigned to the assignee of the present disclosure.
However, while these aforementioned devices may perform suitably
for the currently contemplated procedures, certain modifications
could improve their performance. That is, the annulus pulposus, as
well as certain of the surrounding fluid, is normally more viscous
and less able to flow to provide the "perceptible signal" of the
aforementioned patents.
In order to improve upon these previous embodiments, the location
detection means incorporated in the current embodiments may further
comprise instrumentation or other features allowing for accurate
placement of the device percutaneously. Such instruments may be
calibrated at some portion so as to allow the surgeon to determine
the exact thickness or dimension of the spinal disc component to be
traversed with the fixation device. These placement instruments can
also be comprised of an actual depth measurement instrument whereby
the surgeon can engage the aspect of the disc to which the distal
most portion of the device should engage and then determine the
traversing distance. A location detection means may also
beneficially stabilize the delivery system for the placement of a
repair device in an intervertebral disk.
DESCRIPTION OF THE DRAWINGS
FIGS. 1-3 depict overhead cross-sectional views of a vertebral disc
having a defect therein, in the form of an annulus wall having a
reduced thickness, a partial tear, and a full tear,
respectively.
FIGS. 4-8, and 11 provide a depiction of the placement of various
closure or treatment devices of the present invention.
FIGS. 9 and 10 illustrate various barrier members for use with the
present invention.
FIG. 12 is a cross sectional depiction of a cannula and obturator
for the implementation of the present invention.
FIG. 13 is a partial cross-section of embodiments of the delivery
device and portions of the treatment device of the present
invention.
FIG. 14 is another embodiment of a treatment device and the
delivery device, housed within the access sheath.
FIG. 15 illustrates a cannula and access sheath of the present
invention incorporating a location detector means.
FIG. 16 An access cannula (e.g. needle) positioned into the defect
of FIG. 30.
FIG. 17 depicts an exploded profile view of a cannula and
obturator.
FIG. 18 shows an exploded profile view of a guidewire and
cannula.
FIG. 19 shows an elevated view of the Guidewire positioned into the
access cannula and directed into the disc of FIG. 16.
FIG. 20 shows an elevated view of the Guidewire of FIG. 19
remaining in place as the access cannula is removed from the
patient.
FIG. 21 shows an elevated view of the positioning of an Access
sheath over the Guidewire of FIG. 20.
FIG. 22 shows an elevated view of the Access sheath of FIG. 21 as
the obturator (e.g. dilator) and guidewire of FIG. 21 are
removed.
FIG. 23 shows an elevated view of the activation or deployment of a
location detector on the access cannula of FIG. 22.
FIG. 24 shows an elevated view of the retraction of the access
sheath and deployed location detector of FIG. 23.
FIG. 25 shows an elevated view of a deployment of a locking ring on
the access sheath of FIG. 24.
FIG. 26 provides an elevated view of the access sheath of FIG. 25
and depicting the introduction of the delivery system into the
access sheath.
FIG. 27-32 depict elevated profile views and illustrations of the
deployment and securement of the closure device of the delivery
system of FIG. 26.
FIGS. 33 and 34 show overhead cross-sectional views of a vertebral
disc having a defect therein, in the form of a hernia or bulge in
the annulus, having an intact annulus or extravasation of the
nucleus.
FIGS. 35-38 depicts the placement of various closure or treatment
devices of the present invention.
FIG. 39 illustrates overhead cross-sectional views of a vertebral
disc having a nucleus implant material placed into the nucleus.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Repair of Tears of the Annulus Fibrosis
The annulus fibrosis (AF) of the intervertebral spinal disc is a
lamellar configuration of collagen layers intended to maintain the
soft viscous internal nucleus pulposus (NP), provide for motion and
linkage of the adjacent vertebral bodies (VB). Certain degenerative
or pathologic changes may occur either within the NP or the AF
which can lead to over stress of the AF and subsequent damage to or
tearing of the AF. If left untreated, herniation of the NP may
occur through the tear, and most importantly, the herniation may
progress posteriorly toward the spinal cord and major nerve roots.
The most commonly resulting symptoms are pain radiating along a
compressed nerve and low back pain, both of which can be crippling
for the patient. The AF may also be torn through traumatic injury,
which can lead to progressive degenerative changes and herniation
or ultimately listhesis of the adjacent VB.
An embodiment of the present invention is intended to provide means
by which the AF can be compressed, e.g., along, or across, as
appropriate, the axis of tear, thereby preventing the potential
herniation of the NP through the tear and resultant pain.
FIG. 1 shows a transverse section of the intervertebral disc space
between two adjacent vertebral bodies. The intervertebral disc 16
contains the annulus fibrosis (AF) 3, which surrounds a central
nucleus pulposus (NP) 4. Also shown in this figure are the spinal
cord 1 and the nerve roots 2. In FIG. 1, the annulus is depicted
having a defect 9 therein, wherein the thickness of the annular
wall is reduced, as may occur through, for example, a full or
partial discectomy procedure, where the removal of at least a
portion of the annular wall may be necessary, commonly to minimize
the effects of herniated discs. With reference to FIGS. 2 and 3,
the defect 9 may be in the form of an annular tear, as depicted by
the solid black line through the AF, as may occur in the course of
surgical procedures, injury, or natural degradation of the annulus
fibrosus. A defect, as used herein, refers to any variation or
anomaly from the normal presentation of the annulus, and the term
is deemed to include, for example, full or partial tears, full or
partial excisions, holes, bulges, degradation, thinning,
hyperplasia, or thickening of or in the annulus material. As will
be described more fully below, the damage or defect 9 depicted in
FIGS. 1, 2 and 3 may be repaired in various manners through the
practice of the present invention, for example as can be seen
respectively in FIGS. 4-8.
In order to repair these defects, whether full or partial, the
device of the present invention may serve to fill the defect and/or
apply compression to the annular wall. Furthermore, the present
invention may serve to reinforce the defect area, thereby
preventing further herniation of tissue (e.g., NP) or the expulsion
of nucleus replacement devices or other materials. The defect 9
created by a discectomy procedure may fully penetrate the annulus,
extending through to the nucleus pulposus, and forms an opening in
the annulus, requiring repair in order to prevent the extraversion
of the nucleus.
As can be seen by example in FIG. 4, one embodiment of the
implanted device consists of a barrier element or anchoring member
5 placed within or near the defect 9 in the annulus, preferably
placed against an interior aspect of the annulus such that the
barrier overlaps the defect area, thereby covering the defect and
extending beyond the defect area. The barrier element is connected
to at least one securement element 17 by way of at least one
connecting member 6, here depicted as a pair of connecting members
6, thought it is also recognized that additional connecting members
and arrangements of the connecting members may be beneficial. The
connecting members 6 extend through tissue adjacent the defect 9,
or directly through the defect 9 and are affixed to at least one
securement element 17. In this manner, the barrier 5 is securely
fixed in place against the annulus tissue 3, and is able to
effectively seal the opening or defect, thereby preventing the
escape of nucleus or implanted material within the nucleus, through
the defect 9. The closure of the defect or opening is thereby
achieved without requiring the stretching tissue adjacent the
defect, where tension applied to the sutures directed through the
tissues pulls the tissue faces together to seal the defect. The
type of closure, relying on a barrier to cover the defect is better
suited for use with the tough tissue characteristics of the
annulus.
In some embodiments, at least one sealing member 8 may be deposited
within or against the tissue of the annulus, either directly in the
defect or near the defect 9, and may serve to ensure an adequate
closure of the defect. The sealing member may also be secured with
a filament or connecting member 6. The connecting member 6 may
preferably be a suture, filament, thread, fabric, or other flexible
member. The connecting member may be manufactured from materials
known in the art, e.g., synthetic polymers, natural polymers,
metal, etc., and may be resorbable or non-resorbable. The barrier 5
may be constructed of a biocompatible material (e.g., polyurethane,
resorbable polymer, resorbable collagen or other resorbable or
non-resorbable material). The barrier may be rigid as is the case
with a polymer or metal anchor, or the barrier may be flexible such
as a fabric or other textile such that it may conform to the
tissue. The barrier as used in the practice of the present
invention may be arranged to serve as an anchoring means for the
device, and optionally may serve as a sealing means. The
implantable components (e.g., the barriers, sealing members,
connecting elements, intermediary components, fastening elements,
etc.) of the present invention may be manufactured from a variety
of biocompatible, resorbable or non-resorbable, materials, examples
of which can be found in a non-exhaustive list supplied as Table 1
below.
In some embodiments of the present invention, as shown in FIGS. 5,
6, 7, and 8, the device is capable of applying and maintaining a
compressive force between the outer and inner aspects of the AF 3
at the point where the defect or tear 9 exists, thereby serving as
a treatment device to facilitate healing. With reference to FIG. 7
as an example, one embodiment of the implanted device consists of a
barrier element 5 placed internally of the annulus, which is
connected by way of a connecting member 6 to a sealing element 8,
placed externally to the annulus. The connecting member passes
through the annulus tissue 3 adjacent to the defect 9 and may
preferably be a suture, filament, thread, fabric, or other flexible
member. Alternatively, the connecting member may be a rigid member
capable of resisting the free movement of associated barrier
element or sealing members, and intermediary materials. The rigid
connector element may be capable of resisting an encountered force,
and also serve to maintain tension upon the tissue restrained by
the treatment device. The connecting member may be manufactured
from materials known in the art, e.g., synthetic polymers, natural
polymers, metal, etc., and may be resorbable or non-resorbable. The
barrier 5 may be constructed of a biocompatible material (e.g.,
polyurethane, resorbable polymer, resorbable collagen or other
resorbable or non-resorbable material). The barrier may be rigid as
is the case with a polymer or metal anchor, or the barrier may be
flexible such as a fabric or other textile to conform to the
tissue, in any event, where tension is maintained upon the
connecting member 6 against the barrier, the barrier must be able
to resist being pulled through the defect or opening in the
annulus, and prevent the escape of materials within the annulus
through the defect 9.
FIG. 6 illustrates one embodiment of the present invention for
treating a tear in the annular wall. In a similar fashion to
examples already described, a barrier element 5 is placed
internally of the annulus, which is connected by way of connecting
members 6 to a securement element 17, placed externally to the
annulus. In the embodiment shown in FIG. 6, the tension maintained
by the placement of the closure device serves to assist with
repairing the defect, and or allow for healing to occur, as the
compression applied by the device is able to maintain the relative
positions of the tissues adjacent the defect.
In another embodiment, as depicted in FIG. 7, a barrier 5 may be
placed internally to the annular wall 3, connected to connecting
members 6, extending through the tissue adjacent the defect and
associated with a sealing member 8. This sealing member 8 may
beneficially be a non-rigid material, however, the physical
characteristics of the sealing plug are such that it will deform to
fill and or conform to the defect 9. A securement element, would
preferably be utilized, though the sealing member 8 may also serve
as a securement element. For example, the securement element may be
in the form of a sealing material that swells or changes
conformation upon implantation, such that the connector element may
be secured, thereby maintaining the tension or application of
compressive force upon the defect.
FIG. 8 represents another embodiment of the present invention for
treating a tear in the annular wall, although it is recognized that
a full tear, partial tear or other defects could be treated in
similar fashion. With reference to FIG. 8, this embodiment of the
implanted device consists of a barrier element 5 placed internally
of the annulus, which is connected by way of a connecting member 6
to a securement element 17, placed externally to the annulus, and
includes sealing member 8 placed within the wall of the annulus 3
and/or within the defect 9. In some embodiments of the present
invention, the sealing member 8 may serve to deliver a therapy
(e.g. for the purpose of moderating inflammatory response, aiding
healing, etc.), such as a biologically active agent, examples of
which are listed in Table 2. The sealing member 8 may consist of a
flowable or expandable material (e.g. hydrogel, adhesive, packing
material, etc.) that serves to aid in sealing or adhering the
tissue, so as to prevent the flow of material into or out of the NP
(e.g., loss of NP, or inflow of blood, etc.) through the defect 9
in the AF 3 (e.g. a plug). This may be accomplished by providing a
sealing member 8 that is able to conform to the shapes and surfaces
of the defect 9. It is recognized that the sealing member may be
delivered as a rigid material that is able to swell upon being
implanted in the body, effectively sealing the defect from the
extravasation of nucleus material. The sealing member may
additionally feature a natural material that can act as a matrix
for cellular infiltration and regeneration of the annulus. The
sealing member 8 may also be secured with a connecting member 6'
which, in this depicted embodiment, intersects at least a portion
of the defect 9. As shown, connecting members 6 extend through the
tissue at locations adjacent to defect 9. The connecting members
may preferably be a suture, filament, thread, fabric, or other
flexible member but may also be a rigid member as described
previously. The connecting members 6 and 6' may be manufactured
from materials known in the art, e.g., synthetic polymers, natural
polymers, metal, etc., and may be resorbable or non-resorbable. The
implantable components (e.g., the barriers, sealing members,
connecting elements, intermediary components, fastening elements,
etc.) of the present invention may be manufactured from a variety
of biocompatible, resorbable or non-resorbable, materials, examples
of which can be found in a non-exhaustive list supplied as Table 1
below.
As can be seen in FIGS. 9 A, B, C and 10 A and B, the barriers may
be of any shape or configuration that is suitable for delivery to
the defect site and capable of resisting being pulled back through
a defect after deployment. The barriers may preferably have several
connecting elements attached at various locations of the device. In
some instances, as is shown in 9a, 9b, and 9c, several of the
connecting elements 6 are located at the periphery of the barrier
and these connecting elements 6 are intended for passage through
tissue adjacent an annular defect. In these instances, four
connecting elements 6 are located at the periphery of the barrier
element 5 and serve to anchor the barrier 5 to the tissue adjacent
to the defect. It is recognized that any number of connecting
elements can be used depending upon the geometry and size of the
barrier and defect to be treated. In some instances, for example as
shown in 9b, at least one connecting member 6' can be located near
the center of the barrier. Portions of these non-peripheral
connecting elements 6' are intended for passage either through the
defect itself or through the puncture through which the delivery
instrument has passed. The barriers 5 may be constructed of a
biocompatible material (e.g., polyurethane, resorbable polymer,
resorbable collagen or other resorbable or non-resorbable
material). The barrier may be rigid as is the case with a polymer
or metal anchor, or the barrier may be flexible such as a fabric or
other textile as described previously. The barriers may be
rectangular in shape as shown in FIGS. 9A and 9B, circular/oval as
shown in 9C, or any desirable shape. The barriers may also be
formed into 3-dimensional structures to help them best seal and
repair the defect. As shown in FIG. 9C, the barrier may be
comprised of a flexible membrane 50 (e.g. polyurethane mesh,
collagen sheet, etc.) and a reinforcing expandable membrane 52
(e.g. nitinol wire, polymer ring, etc.). The barrier of FIG. 9C is
suitable for being collapsed and stored within the elongate
delivery instrument and, upon delivery into the area adjacent to
the defect, the reinforcing membrane 52 causes the barrier 5 to
resume its original oval shape so that is may conform to the defect
site. As shown in FIG. 9C the barrier may be attached to several
connecting elements 6, in this case 4.
As illustrated in FIG. 10A, the barrier 5 may also contain small
barbs or points 7 to interface with the internal or external
surface of the AF or surrounding tissue to aid in securing the
device and prevent it from being dislodged.
As illustrated in FIG. 10B, the barrier may consist of multiple
barrier elements that once deployed are able to seal the defect
and/or resist being pulled through the defect. The device of FIG.
10B is suitable for being collapsed and stored within the delivery
instrument in a first conformation, and upon delivery into the area
adjacent to the defect, barrier may arrive at a second
conformation, for example, the elements 54 of FIG. 10A can pivot at
location 55 and expand into the barrier 5 of cruciform shape shown.
It is recognized that barriers 5 may be specifically shaped for a
particular purpose, that is, barriers intended to be inserted into
the interior of the annular wall may have a first orientation,
shape, or curvature, while another barrier intended for use outside
of the annular may feature a second orientation, shape or
curvature.
It is also recognized that various arrangements of barriers and
connecting members may be necessary. For example, it might be
beneficial to utilize a single barrier on the exterior of the
annulus, and place a plurality of barriers in the interior of the
annulus, all connected by at least one connecting member, or
alternatively, the arrangement may be reversed, with a single
interior barrier and a plurality of exterior barriers. It is
recognized that the barriers described above may additionally
feature some application (e.g. coating) of a sealing material (to
be discussed below) to aid in maintaining annulus integrity against
leakage. The barriers, or other members, may also contain a marker,
additive, or other material that can be visualized with x-ray or
other imaging technologies to assist with the placement of the
device and potentially allow for longer term follow-up of the
device location.
The materials of the present invention that are resorbable may
comprise a porous tissue matrix material (PTM). This PTM material
will preferably have an interconnected porosity, and sized to
encourage the invasive growth of new cellular material. The
interconnected porosity also serves to ensure adequate fluid flow
to provide an optimal growth environment for the invasive cells.
The ingrowth of new cellular material will beneficially encourage
the incorporation of the device material into the nearby tissues,
and provide for biomatching or compliance matching, where the
device material and components present similar physical
characteristics as the original tissue.
Referring to FIG. 11, where the defect 9 extends fully through the
annular wall, and may be created, for example, as a consequence of
a full discectomy, the intermediate or sealing component 8 is
preferably capable of filling the entire defect void created by the
removal of a portion of the annulus. The sealing member 8 may be
locked in place, and against adjacent walls of the annulus by an
applied pressure created through compression applied through the
connecting member 6 and external barrier member 5''.
In practicing the present invention for the repair of a partial or
full defect in the annular wall 3, an access sheath (e.g. a
cannula, solid probe, rod, needle, etc.) 13 or series of sheaths,
optionally housing an obturator 14, as depicted in FIG. 12 may be
inserted through a percutaneous incision in the external skin and
extended through underlying tissue to the AF using techniques known
in the art. It is recognized that in some circumstances, a series
of sheaths may be used to gradually dilate an access tract to, and
in some instances, through the defect. If desired, a final sheath
13 can be left in place, through which the delivery instruments of
this invention can be positioned. Guide wires or other similar
elements can be used to guide the delivery instrument to the defect
site, through techniques common in the art.
In an embodiment, the access sheath 13 through which any subsequent
instruments or components may be inserted is preferably of a fixed
length. The subsequent instruments which may be directed through
the sheath may incorporate that fixed length into their shafts, and
extend out the distal end of the sheath by a precisely determinably
amount, as they may be calibrated or have markings, in order to
allow the surgeon to determine the depth of penetration into the
target tissue (e.g., into the disc, thickness of the annulus, and
zone of nucleus). As the sheath and obturator are directed to the
target site, the obturator may be removed and a trocar or tissue
dilator (for example, tissue dilator 18 of FIG. 21) is used to
initially penetrate into the annulus fibrosis (AF) at the zone of
the defect or tear. A sharp trocar or tissue dilator (which is
preferably calibrated along at least a portion of its length) may
be inserted through the access sheath 13 to the surface of the AF
at the location of the tear and confirmed in some manner (e.g., via
radiography). It is envisioned that multiple increasing diameters
and/or lengths of trocars or tissue dilators may be used to
gradually open a lumen within the AF. The instruments inserted into
the living being, (e.g. the sheath, trocar, and obturator, etc.)
may feature monitoring elements (e.g., radiopaque markers, bands,
penetration markers, orientation markers, calibration, etc.) to
allow accurate tracking, placement and implementation of the
devices using techniques known in the art (fluoroscopy, x-ray
visualization, etc.). The trocar may then be advanced into the
disc, for example through the AF to the level of the NP. The trocar
may then be removed, thereby creating an accessible open lumen
within the cannula or access sheath 13, such that the elongate
delivery device 15 of FIG. 13, shown here in cross-section
containing an embodiment of the treatment device, may be inserted
into and extend through the access sheath 13 as depicted in FIG.
14.
As illustrated in FIG. 13, one embodiment of the treatment device
or closure device includes a distal barrier 5 attached to at least
one connecting elements 6 and 6'. The barrier element 5 depicted
here is in the form of a flexible mesh-like material capable of
being collapsed and stored within the distal portion of the
delivery instrument 15 for later ejection into the wound area for
placement adjacent the opening or defect upon deployment. In
another embodiment, a sealing element may be included as an
intermediary component that is located contiguous with the
connecting members 6' and/or 6, and adjacent the barrier element to
facilitate the filling of the defect upon delivery. Also shown in
FIG. 13 are passage means 60 and 60', which are stored while
recessed, in channels 62 and 62', respectively, in the body of the
delivery instrument 15. As will be described later, the passage
means 60 and 60' in this embodiment can be extended out of the
distal portion of the channels to pierce the tissue surrounding the
defect. As will also be described later, the passage means are used
to pass the connecting member(s) through the tissue adjacent to the
defect. The device may have one or more passage means, optimally
the device would have at least two. Also shown in FIG. 13 are
positioning elements 70 and 70'. The positioning elements are
deployed to position a portion of the connecting member 6 and/or 6'
to a location where the passage means 60 and 60' can cause the
connecting members 6 and 6' to pass through the tissue adjacent the
defect. As will be described, the positioning elements can expand
laterally, and preferably radially from the elongate delivery
instrument 15 such that when passage elements 60 and 60' are no
longer recessed in channels 62 and 62', but instead extend distally
from the body of the elongate delivery instrument 15, the passage
means will intersect with the desired portion of the connecting
members 6 and 6'. Preferably, the passage means 60 and 60', will
interlock or become attached to the connecting members 6 and 6'
upon intersecting, and as the passage means are retracted, they
will draw a portion of the connecting members with the passage
means, thereby directing at least a portion of the connecting
members through the tissue adjacent the defect.
FIG. 14 depicts an alternative embodiment of the delivery device 15
within the access sheath 13, and is prepared for being introduced
into the disc through percutaneous puncture, and extended into an
aperture created in the AF to the level of the NP for delivery and
implementation of the remaining components of the device (e.g. the
closure device elements). FIG. 14 depicts an alternative form of a
barrier element 5'', wherein the barrier element 5'' is fabricated
from a more rigid material such as nylon, PLGA, etc. In this
embodiment, the delivery device 15 may be calibrated along its
proximal end relative to the proximal edge of the access sheath 13
to allow the surgeon to determine when the barrier element 5' has
traversed a distance approximately equal to the thickness of the
AF. Alternatively, other location detection mechanisms may be
utilized in ensuring accurate placement of the delivery device for
placement of a fastener or closure device.
With reference to FIGS. 13 and 14, the delivery device 15 may be
shaped or incorporate elements that deploy the device components
(e.g. barrier element 5, sealing element, etc.), such as a tamping
or ejecting mechanisms, or a rod that can be extended down through
the elongate delivery device 15 to eject the closure device
elements, such as the barrier, as may be necessary.
In this or other embodiments, the use of a means for location
detection may be beneficial. In FIG. 15 there is shown embodiment
of a locating device for effecting the proper positioning of the
access sheath 13 or other deliver device within the annulus or
nucleus. As can be seen in FIG. 15, the depicted embodiment of a
locating device basically comprises a conventional obturator 14
providing a passageway 402 extending longitudinally down
substantially the length of the device, preferably internal to the
obturator, although external may be capable of functioning
similarly. In the embodiment having an internal passageway lumen
402, a detection port 404 extends radially inward into the device
communicating with the distal end of the passageway 402, while a
proximal port 406 extends radially inward into the device
communicating with the proximal end of the passageway 402. The
locating device is arranged such that it may be fully inserted
within the access sheath 13 and extend a precise amount beyond the
end of the access sheath, as shown in FIG. 15, and further the
proximal port does not enter the proximal end of access sheath 13,
thereby ensuring that proximal port 406 remains accessible or
visible to the operator.
The length of the annular passageway 402 is selected so that when
the obturator 14 of the locating device shown in FIG. 15 is fully
extended within the access sheath 13 and the distal end of the
sheath is located within the interior of the annulus or lumen, the
detection port 404 of the passageway 402 extends just beyond the
free end of the sheath, while the entrance port 406 is accessible
to the operator. The detection port 404 forms a window, which is
exposed to the material in the annulus.
In another embodiment of the location detector of FIG. 15, a
flexible or reconfigurable member (e.g. a probe) (not shown), may
be inserted into proximal port 406 and extended through the
passageway 402, exiting at detection port 404, such that the
flexible probe or member may be used to probe the tissue, thereby
using, for example, tactile feel to locate the sheath or other
insertion member, such that a device may subsequently be accurately
placed.
In another embodiment of a location detector, sensors (not shown)
may be placed at or near the distal end, such as within detection
port 404 to confirm accurate placement. Such sensors may be in the
form of, for example, optical sensors or pressure sensors that may
be exposed to the tissue or fluid during placement of the device,
and generate an indicator signal or other feedback for the operator
and enable confirmation of accurate placement of the device.
Description of an Exemplary Procedure for Repair of a Defect in the
AF Using the Device of the Present Invention
With reference to FIG. 3, there is depicted a typical defect 9 in a
vertebral disc 16, here shown as a full tear in the annulus 3. In
the practice of the present invention, various techniques known in
the art may be utilized for the introduction of the closure device
through a delivery device in order to repair such a tear in the
annulus. The following description of one delivery technique is for
example only, and is not intended to limit the inventor to only
this practice, as other similar or equivalent delivery techniques
are available and known in the art, and the practice of the present
invention through these equivalent procedures is inherent within
the description.
As depicted in FIG. 16, an access cannula 13 (e.g. a needle) may be
positioned through a defect 9 in the annulus 3, and the needle
extended into the interior of the annulus (i.e. the nucleus
pulposus 4) using standard techniques known in the art, preferably
radiographic techniques (e.g. x-ray). As shown in the exploded view
of FIG. 17, the cannula 13 may initially have an obturator 14 as
shown, which may serve to prevent tissue from entering into the
central lumen of the cannula while it is being directed through
tissue. Upon insertion of the cannula 13 into the interior of the
disc 16, the obturator 14 may be removed, leaving an empty lumen in
the cannula 13 for the introduction of the delivery device, as will
be discussed. Alternatively a guidewire 12 or other wire-like
element may be introduced into the cannula (as can be seen in
exploded form in FIG. 18, and in place in FIG. 19). The use of a
guidewire 12 will allow the replacement of the first inserted
cannula or access sheath 13, to be replaced with another access
sheath suitable for passing the elongate delivery device
therethrough (to be discussed) that may be advanced along the
placed guidewire 12.
With reference to FIG. 20, after removal of either or both of the
obturator 14 (from FIG. 17) or the cannula 13 (from FIG. 19), the
guidewire 12 or wire-like element can be left in the puncture or
defect 9 and may serve to guide access sheath 13 suitable for use
with the delivery system of the present invention (e.g., delivery
system 15 of FIG. 13 or 14) to the appropriate position at the
target site. As depicted in FIG. 21, the access sheath 13 may
optionally utilize at least one tissue dilator 18 (e.g. trocar,
obturator, etc.) that is arranged to expand the initial opening or
defect 9 in the annulus 3 to a size capable of allowing the
penetration of the access sheath 13, and associated elongate
delivery device 15 housing a closure device into the opening
created. It is recognized that a series of tissue dilators 18 and
or access sheaths 13, increasing in size may be utilized to achieve
an aperture of greater size in the tough annulus layer 3 than the
original opening or defect 9 created in FIG. 16. In use, the tissue
dilator 18 is inserted through the access sheath 13, and extends
distally therefrom, forming a tapered snout that serves to expand
the tissue, such as in annulus 3, to the point where the access
sheath 13 suitable for use with the delivery device 15 may be
inserted.
As the access sheath 13 is positioned over the guidewire 12 and
advanced into the aperture, as seen in FIG. 21, various techniques
for ensuring the positioning of the device are available. For
example, radiopaque markers (not shown) can be used to properly
locate the sheath at the ideal position. Alternatively, other
location detector mechanisms, as described previously or known in
the art, may be utilized.
In the embodiment where an access sheath 13 incorporates an
expandable or reconfigurable locking member 22, as can be seen with
reference to FIGS. 22-26, located at or near the distal end of the
access sheath 13, the locking member 22 may also function as a
location detector. In this manner, the actuation of the expandable
or reconfigurable locking member may provide feedback or tactile
sensations to the operator as to the type of tissue is being
encountered, thereby allowing the operator to distinguish placement
within the annulus 3 from placement within the nucleus 4. For the
practice of this embodiment, it is preferred that the tissue
dilator 18 and wire 12 be removed, as depicted in FIG. 22, leaving
the access sheath 13 penetrating into the disc 16.
As shown in FIG. 23, actuation mechanism 23 is used to deploy or
reconfigure the locking mechanism 22 to provide location detection.
The actuation of the expandable or reconfigurable locking member 22
may be accomplished by various means (e.g. inflation, or mechanical
actuation). As shown in FIG. 23, with this particular embodiment,
actuation mechanism 23 is preferably located at the proximal end of
the access sheath 13, and may be rotatable, and upon rotation, or
in the case of an inflation port, upon delivery of an inflation
charge, serves to actuate the locking member 22 at the distal tip
of the sheath 13, causing the locking member 22 to expand via one
of several mechanisms (e.g. balloon expansion, nitinol wings,
etc.). In the instance where the actuation of the locking member 22
were to cause the locking member to encounter tough annulus tissue,
this would serve as an indicator to the operator that the sheath
must be advanced into the nucleus, until softer nucleus material is
encountered, allowing easier expansion of the locking member 22.
The mechanisms (e.g. balloon, nitinol wings, etc.) may also be used
to prepare a physical space for the delivery of the device. For
example, the balloon can be inflated to a large initial diameter to
stretch or otherwise move tissue. Then the balloon can later be
reduced in size to provide a deployment space for a component of
the device (such as a barrier or sealing member). In the case of an
embodiment having another expandable mechanism, such as nitinol
wings, the expandable mechanism may be expanded and optionally
through the rotation or translation of the access sheath, or other
instrument upon which the mechanisms are mounted, a physical space
can be created to allow for proper deployment of the remaining
components of the device.
With reference to FIG. 24, the operator or surgeon may retract the
access sheath 13 until the desired location is achieved using a
location detection means as described preciously. Resistance may be
felt as the locking member 22 first traverses relatively freely
through a portion of the nucleus 4 and subsequently encounters the
tougher annulus 3 tissue, thereby providing the resistance to
further refraction. Optionally, and as shown in FIG. 25, a locking
mechanism (e.g. a locking ring) 24 may be advanced down the access
sheath 13 in a proximal to distal fashion toward the puncture
(i.e., against the skin or tissue of the patient) to stabilize the
access sheath 13.
As shown in FIG. 26, the elongate delivery device 15 containing the
closure device of the present invention may now be inserted into
the access sheath 13. In a preferred embodiment, the anchoring or
barrier element 5 is contained within and in place at or near the
distal end of the delivery device 15 (as described previously with
reference to FIGS. 13 and 14), and is temporarily maintained in
alignment with the axis of the access sheath 13 to allow passage
into the sheath 13. It is also contemplated that the delivery
device 15 could be introduced into the defect without the use of an
access sheath. The delivery device 15 could be modified to include
a passageway that would permit it to be guided into the defect site
over a guide element 12 (e.g. guidewire, k-wire, etc.). The
delivery device 15 could also include a rounded or more atraumatic
tip to assist with passage through the tissue.
As shown by FIG. 27, upon full insertion of the delivery device 15
into the access sheath 13, the distal portion of the device 15
extends beyond the access sheath 13. Also with reference to FIG.
27, a locking tab 26 may be incorporated onto the proximal end of
the delivery device 15. As the delivery device 15 is fully
inserted, the locking tab encounters the access sheath 13. The
locking tab 26 is capable of one-way movement over the access
sheath's 13 proximal end, and will then become engaged with the
access sheath such that the access sheath 13 and the delivery
device 15 are now interlocked as one unit.
As shown in FIG. 28, the expandable or reconfigurable locking
member 22, located at or near the distal end of access sheath 13,
may de-actuated, such as through the action of actuation mechanism
23, such that it reverts back to its original, non-expanded
state.
Also as shown in FIG. 28, activation of a secondary actuation
mechanism (e.g., lever) 80 causes the deployment of positioning
elements 70 at the distal portion of delivery instrument 15. As
described previously, the delivery device may have any number of
positioning elements 70 as is necessary for the application. The
positioning elements may extend in one axis, presenting a pair of
positioning elements upon actuation. Alternatively, several
positioning elements (e.g. 3 or more) may be simultaneously
deployed to form a flange or series of protruding elements
extending laterally from the body of the delivery device 15 in many
axis or orientations.
If desired, the access sheath 13 and delivery device 15 can be
withdrawn as one unit to a desirable location as is necessary. For
example, as shown in FIG. 28, delivery device 15 and access sheath
13 are withdrawn as one unit from the defect until the laterally
deployed positioning elements 70 contact the interface between the
annulus 3 and the nucleus 4. In this embodiment, positioning
elements 70 may also be capable of functioning as a location
detector in a manner similar to that previously described with
reference to the expandable locking member. In this manner, the
actuation of the expandable or reconfigurable positioning elements
may provide feedback or tactile sensations to the operator as to
the type of tissue is being encountered, thereby allowing the
operator to distinguish placement within the annulus 3 from
placement within the nucleus 4.
As shown in FIG. 29, activation of plunger 90 causes the deployment
of passage elements 92 from the distal portion of delivery
instrument 15. As described previously, the device 15 may have any
number of passage elements as is necessary for the application. The
passage elements can be constructed and configured to readily
pierce through the tissue that is adjacent the delivery instrument
(e.g., a needle). Each passage element 92, upon deployment in
response to activation of plunger 90, is arranged to intersect a
respective positioning means 70 and thereby engage the connecting
members 6 associated with each positioning means. The engagement of
the passage means and the connecting member may be accomplished in
a manner that ensures the secure, one-way, connection between
connecting member 6 and the respective passage element 92.
As shown in FIG. 30, plunger 90 may then be refracted, thereby
withdrawing the passage means 92 back through the tissue, and into
the recessed channels of the delivery instrument 15. The retraction
of the passage elements 92 causes the securely attached connecting
elements 6 to pass along the same passage, through the tissue
adjacent to the delivery instrument and enter into the recessed
channels of the delivery instrument. After complete refraction of
the passage elements, a portion of the connecting elements remain
within the internal lumen of the delivery device, attached to the
remaining components of the fastener, and another portion of the
connecting element (e.g., a filament) is extended along the passage
created by the deployment of the passage means, and attached to the
passage means contained within the recessed channels of the
delivery device. Secondary actuation mechanism 80 may then be
deactivated, thereby collapsing the positioning elements 70 back to
their original, more compact state.
As shown in FIG. 31, the delivery instrument 15 and access sheath
13 can be withdrawn form the defect site as one unit. Upon
withdrawal of the delivery instrument 15, the components of the
fastener may now be deployed; barrier member 5 is deployed from the
distal portion of delivery instrument 15 and the continued
withdrawal of delivery device draws the connecting elements through
the tissue that is adjacent to the defect 9. Tension upon the
fastener components (e.g., barrier member, sealing member and
connector elements, etc.) may be maintained through the at least
one connector element 6 by the retraction of the delivery device
15, and the resistance of the barrier member 5 as it encounters
thicker nucleus tissue or tough annulus tissue, as depicted in FIG.
32.
As further depicted in FIG. 32, connecting elements 6 can be placed
in tension, such as being pulled taught, by continued withdrawal of
the delivery instrument, and securement member 17 can be advanced
along the connecting elements 6 to a desired position to secure the
barrier member 5 and the connecting members 6 at the desired
location to help approximate and or treat the tissue contiguous to
the defect site 9. Subsequently, excess connector element may be
removed, or trimmed to minimize the opportunity for complications
as healing occurs (e.g., infection, irritation, scarring,
etc.).
The securement element 17 may be positioned, in one embodiment,
against the outside of the puncture in the annulus 3, and internal
to the patient. Alternatively, the fastening element 17 may be
placed outside of the patient and against the skin where the
connector element enters the tissue. The securement element 17 can
be any of a variety of tension maintaining devices, for example, a
locking washer, a knot, or a variety of elements or combination of
elements may be utilized. The securement element 17 could be
pre-stored within the delivery instrument 15 or it could be added
to the connecting members 6 by the physician during the procedure.
Further, a small-elongated tamper tube or other instrument may be
utilized to push down or advance the securement element 17. The
tube is preferably removed after securing the securement element
17. Alternatively, a pulley configuration could be used with a
securement element 17 in the form of a sliding locking knot, and
would not require the use of an elongated tube to apply tension, as
the operator applies tension simply by pulling on the connector
element 6, whereby the pulley arrangement and sliding locking knot
are arranged to maintain that tension. Glue or some other sealant
or adhesive could also be used to secure the device at the desired
location.
Various embodiments of a closure device can be utilized in the
practice of this invention, as have already been described. As
depicted earlier in FIG. 4, a sealing member 8 associated with a
portion of the flexible connector element 6 may be deposited within
the tissue as desired. With this embodiment, continued refraction
of the access sheath 13 and delivery device 15 results in the
deployment of the sealing member within the annulus tissue 3.
Altering characteristics necessary for the various embodiments of
the closure device, such as manipulating the length of the
connector element 6, and varying the placements of the access
sheath 13 can achieve the deployment of the various described
embodiments of the closure device.
After the closure device is fully positioned at the tissue defect
9, any extraneous connector element 6 or suture may be removed. As
appropriate any of the embodiments of the device described in the
specification may be used to deliver various medications at the
puncture site and to the surrounding tissues. The delivery of such
medications may be accomplished as a coating of drug delivery
material associated with one or more of the fastener or device
components, such as the barrier or anchor, sealing member,
connector means, etc. It is also recognized that these or other
components of the device may be manufactured from a resorbable
material to deliver biologically active agents as the components
bioerode, thereby forming a depot. A non-exhaustive list of
examples of drugs or biologically active agents is provided in
Table 2.
Repair of Herniated or Bulging Annulus Fibrosis
An annular defect such as a bulge or herniation may be caused by or
be the result of weakening in the AF secondary to physiologic
changes to the AF or NP, and the AF may weaken and protrude from
its normal anatomic space pushed by the internal NP as can be seen
in FIG. 33. In more severe cases, the AF 3 may rupture and allow
extravasation of the NP 4 contents to the surrounding anatomy (as
depicted in FIG. 34). Symptoms may arise when the herniation
(bulge) or leakage of the NP through the defect 9 in the AF 3
impinges on the nerve root 2 or spinal cord 1. There are many
therapies currently utilized for treatment of the herniation
(bulge) and resultant pain, starting with conservative therapies
such as bed rest and pain medicines, to epidural injections, to
open or minimally invasive discectomies or to complete discectomy
and fusion of the disc space and adjacent vertebrae. An object of
this invention is to provide a minimally invasive means to contain
leakage or to reduce the bulge or defect 9 created by one of the
invasive treatment means in an annulus to prevent impingement on
the nerve roots or spinal canal.
The previously described embodiments may also be useful for
treating herniated or bulging annulus defects. FIG. 35 illustrates
an additional embodiment of the device specifically envisioned for
the treatment of bulging or herniated discs. The treatment device
consists of a distal barrier 5' which is arranged to rest against
the external aspect of the AF 3 directly opposite the bulge 9 in
disc 16 in the anterior-lateral portion of the AF 3. Connecting
elements 6 traversing through the AF 3 and NP 4, connects the
distal barrier element 5' to another barrier, proximal barrier 5'',
which is arranged to rest against the bulge 9 in the affected part
of the AF 3 in the posterior part of the disc. The barriers 5'
& 5'', as previously described may be constructed of a
resorbable polymer, resorbable collagen or other resorbable or
non-resorbable material. The barriers 5' and 5'' may be somewhat
flexible, but not so much as to pull through the delivery opening
or defect 9 upon the application of compression. In the preferred
embodiment, barrier 5' is comprised of a flexible membrane such as
a polyethylene mesh and barrier 5'' is a more rigid material such
as an injection molded plastic. The barriers 5' and 5'' may also
contain small barbs or points 7 (as can be seen in FIG. 10A) to
interface with the internal or external surface of the AF 3 to
prevent dislodging. Connecting members 6 may preferably be a
suture, similar to that described above, and may be manufactured
from polymers known in the art, including synthetic and natural
polymers. In some embodiments of the device, the connecting member
may also be associated with a sealing element 8, as has been
described above. The sealing or intermediate component 8 may be
arranged within the walls of the annulus 4, as shown in FIG. 11,
and/or all or a portion of the NP 4, as shown in FIG. 36. The
intermediate component or sealing member 8 may function to prevent
the escape of NP through the defects 9 or openings created by the
implanting of the closure device. In an embodiment, the
intermediate material or sealing member 8 may be treated with
fibrin glue or other means by which it can stick to the opening or
defect 9, or alternatively may serve to deliver at least one
therapy, drug or biologically active agent, such as those listed in
Table 2. It is recognized the suture or connecting member 6 itself
may feature a coating of a sealing material or a therapy that may
be delivered upon implantation in the living being. All of the
closure device components, including barriers 5, sealing member 8
and connecting members 6 may be non-resorbable for permanent
implantation, partially resorbable, or completely resorbable, such
that a temporary implant may be achieved.
It is recognized that various other combinations of barrier
placement are possible, varying in location and number. Barrier
locations may vary within a given embodiment, such as is depicted
in FIG. 37, having multiple distal barriers 5' against an interior
aspect of the annulus 3 and within the nucleus 4, and having a
proximal barrier 5'' inside of the nucleus, inside the annulus,
replacing a portion of the annulus, or exterior to the annulus. As
shown here and in some other embodiments, the placement of multiple
barriers may be necessary to provide the necessary levels of
support. Such multiple barriers placements may be seen in the
exemplary embodiment of FIG. 37 where multiple distal barriers 5'
are operating in parallel to maintain tension upon connecting
members 6 and upon proximal barrier 5''.
In an alternative embodiment of the device envisioned for the
treatment of bulging or herniated discs, as depicted in FIG. 38,
the device features multiple barrier members 5' which are arranged
to rest against the exterior aspect of the AF 3 opposite the bulge
9 in disc 16 in the anterior-lateral portion of the AF. The
placement of multiple barrier members as shown herein serve to
provide increased surface area over which to distribute a given
load, which will necessarily be less than the load per unit area
imposed by a single similarly sized barrier placed against a bulge
or defect 9, thereby overcoming the bulge and restoring the normal
appearance of the annulus 3.
With reference to FIGS. 35 and 36, depicting the process for repair
of a defect 9 in the form of a hernia (bulge). In practicing this
embodiment of the present invention for the repair of a herniated
disc or bulge or defect 9 in the annular wall 3, a cannula or
access sheath 13 and obturator 14, as described above with
reference to repairing a partial or full defect in the annular
wall, may be inserted percutaneously and directed towards the
annular wall, preferably towards the defect 9 in the annulus. As
described previously, once the cannula 13 has passed through the
soft tissue and is resting in the proper location against the
annulus 3, ideally at the location of the herniation or bulge 9,
the obturator 14 is removed and a trocar or tissue dilator 18 may
be inserted and may be advanced into and/or through the annulus,
thereby creating or expanding an aperture for the insertion of the
delivery device. Furthermore, and in the case where the barrier 5'
is to be rested against the outer aspect of the opposing portion of
the AF 3, the trocar or tissue dilator 18 may be advanced through
the opposite AF as well. The insertion of the trocar may be
performed using standard techniques known in the art. Upon
verification of placement of the trocar completely through the disc
16, such as is possible through the employment of monitoring
features such as detection location features (e.g., calibration of
the trocar, radiographic visualization, or other means) the
delivery device 15 housing the closure device may be inserted
through the access sheath 13, and through the nucleus 4 space,
exiting the opposite side of the AF.
Once the delivery device has been passed through the AF, NP and
opposite AF the deployment of the fastener device is performed to
arrive at the embodiment as depicted in FIGS. 35 and 36 having a
distal barrier 5' external to the annulus 3. The steps for
deployment and securement of the fastener components may be
achieved in a manner similar to that described previously with
reference to FIGS. 19-32, altering the components and placements as
needed to achieve the desired outcome.
Alternatively, the delivery device may remain within the NP and not
extended out the opposite AF, and may deploy one or more distal
barrier 5' against the internal aspect of the AF 3, with the result
as depicted in FIG. 37. Deployment may occur by depositing the
closure device components into place from the delivery sheath 15,
for example, by utilizing a rod or other pushing device directed
through the delivery sheath from a proximal location, which upon
contacting one or more components of the closure device causes each
component to exit the distal end of the delivery sheath. The
location of each component of the device may be confirmed by
various monitoring mechanisms as known in the art, e.g., radiopaque
or other visible markers in combination with x-ray imaging or
fluoroscopic imaging, positional markings or bands, etc.
Subsequently, and preferably as the delivery device 15 and/or
access sheath 13 is retracted, the connecting member 6, such as a
suture may be deployed, optionally in conjunction with a soft
intermediate component or sealing member 8 of the device, as can be
seen in FIG. 36. As previously described, the intermediate
component 8 may be made of a polymer material, and may be
resorbable (e.g., collagen). Furthermore, the intermediate
component may contain some bioactive substance, therapy, or drug,
such as those listed in Table 2. It is recognized that any of the
resorbable or non-resorbable components utilized in the practice of
the invention may also beneficially delivery a biologically active
agent as well, such as pain reducing or inflammatory reducing
agents, or other drugs. The intermediate component 8 including any
bioactive substance, either together, or alone, may act to improve
the healing of the defect. It is recognized the intermediate
component 8 may be made of a rigid polymer similar to the barrier
5. Compression may be applied to the AF 3 and the bulge defect 9
upon removal of the delivery device 15 and/or annular sheath 13
from the disc 16, and deployment of holding mechanism or fastening
element 17 (e.g., an automatic slip knot) which when pushed against
the proximal barrier 5'', or in the case of a rigid intermediary
component, the holding element may be pushed against the
intermediary component 8, and maintains tension upon the connecting
member 6. This tension results in compression created between
barriers 5' and 5'', such that the act of compression alone may act
to reduce the bulge defect 9 in the AF 3, thereby relieving or
preventing impingement on the nerve root 2 or spinal cord 1, and
resulting pain or harm. Additionally, the implanted fastener or
closure device may act to prevent subsequent extravasation of the
contents of the NP 4 through the bulge or defect 9, and may provide
a scaffold, such as may occur if made of a collagen or other porous
material, to support the regeneration of the AF. The internal
connector or coupling mechanism 6, extending out from the disk
proximally may then be removed at a convenient location to
encourage healing, e.g., such as being severed at the surface of
the skin, in order minimizing irritation, inflammatory response and
opportunity for infection.
Repair of the Annulus Fibrosis Secondary to Placement of a Nucleus
Pulposus Implant Material
Newer approaches to the repair of the degenerated intervertebral
disc and specifically the degenerated NP have envisioned the
removal, replacement, and/or augmentation of the natural NP
material with an artificial nucleus replacement material designed
to mimic the natural mechanical properties of the NP. In this
manner, normal disc function may be restored by the insertion of a
synthetic or natural material through the annulus and into the
nucleus.
As can be seen in FIG. 39, the nucleus replacement implant material
25 may be a material capable of being delivered by a delivery
apparatus 27 (for example, being injected via a needle, cannula or
other suitable instrument, or being placed through a cannula,
sheath or other suitable instrument), into the region of the
nucleus 4, either with, or without removing the existing NP. The
material 25 may then remain entrapped, either permanently or
temporarily, within the annulus 4, and restore the natural
mechanical function of the nucleus pulposus 4. Examples of
materials suitable for injecting and serving as a nucleus
replacement include synthetic or natural hydrogels (e.g., collagen
gels, PEC gel, etc.) Alternatively, an injectable implant material
25 may be injected as a liquid, hydrogel, or paste, and harden or
cure in-situ to become a self-supporting implant material 25. This
material may serve to supplement the mechanical properties of the
degenerated NP, or in the case of complete nucleus removal, the
implant material would replace the NP and mimic the natural
biomechanical and viscoelastic properties of the disc.
Alternatively, the nucleus implant material 25 may be a
self-supporting material, resilient or otherwise (e.g. solids,
porous foam, collapsible resilient cage, disc or stent structure,
etc.), at the time of being implanted. There are currently several
developmental attempts to address this approach, most notably in
the form of a device utilizing a partially hydrolyzed
polyacrylonitrile housed within a polyethylene jacket (manufactured
by Raymedica), and an implant utilizing Aquacryl 90 which is a
modified polyacrylonitrile (PAN) that can take up to 90% of its
weight in water (manufactured by Replication Medical). This
material is bonded to internal Dacron meshes and is partially
hydrated and upon insertion provides anisotropic axial
expansion
The self-supporting implant material 25 utilized in this embodiment
of the present invention may be provided in various shapes or
conformations (e.g., collapsed, preshaped to a particular portion
of the disc or the entire disc, etc.). The implant material 25 may
be implanted in a first conformation, and following implantation
take on a second conformation, for example, a collapsible implant
may expand after being placed within the nucleus due to physical
means or rehydration, and arrive at a second conformation due to
the anisotropic properties of the material.
In the practice of the technique of NP replacement or augmentation,
the integrity of the natural AF 3 would necessarily be compromised
to allow the insertion of the implant material. For example, in
order to facilitate delivery of the NP filling implant material 25,
and in the case of an injectable implant material 25, a delivery
apparatus 27 in the form of a needle may be directed through the
soft tissue to the outer level of the AF 3, then through the AF and
into the nucleus 4 in order to deliver the implant material 25. The
delivery apparatus 27 upon penetrating through the AF, may be
directed through an existing defect, or alternatively may create a
defect 9, which may or may not require repair through the
techniques described herein. It is also a technique that a
cannula/obturator may be a suitable delivery apparatus 27 for a
nucleus replacement implant material 25, and may be inserted to the
level of the AF 3, an opening created either through the placement
of multiple trocars through the AF or alternatively through the use
of a coring/cutting tool to create a lumen in the AF for the
removal of the NP and subsequently for the injection of the
material. Alternatively, for a solid implant material 25, an
opening in the AF must be created to allow the removal of the
degenerated NP and insertion of the implant material. In order to
implant solid or self-supporting devices whose size is at or near
that required to fill the nuclear space 4, a relatively large
opening or defect 9 must be utilized or created in the AF 3 to
allow removal of the NP material and insertion of the
self-supporting implant material 25. If left un-repaired, there
have been reports in the literature of expulsion of such devices.
It is recognized that a collapsible or deformable self-supporting
implant may serve to minimize the opening required to implant the
device. In any event, it is desirable to contemplate the filling
and repair of the defect 9 in the AF 3 to reduce the risk of
expulsion of the implant material 25 and to support the repair and
regeneration of the AF. Furthermore, in order to prevent potential
extravasation of the filling material 25 after implantation, and to
reinforce the mechanical integrity of the AF 3 or to potentially
regenerate the AF, a fastener or closure device of the present
invention may be utilized to ensure that the opening created in the
AF to deliver the NP filling material is closed, as can be seen
with reference to FIG. 11, where the nucleus 4 would be replaced
with an implant material (not shown). The implant materials 25
contemplated may utilize natural matrices, which can facilitate or
enhance the in-growth of cells and tissue and ultimately facilitate
the regeneration of the AF, providing a more natural construct.
Following the implantation of the artificial NP implant material 25
(whether injectable or self-supporting), the fastener or closure
device of the present invention may be directed through the same
access opening in the annulus through which the injection or
insertion occurred, to seal the opening or defect 9. This repair
may occur in a substantially similar manner as has been described
with reference to any of the techniques described above for
repairing a defect in the annulus, particularly the techniques
described to treat the defect remaining in a discectomy procedure.
These techniques are particularly well suited for repairing defects
that are created through the use of injectable nucleus replacement
materials. Especially in the case of NP repair or replacement with
a solid implant, there may be a need to repair a much larger breach
in the AF.
Any or all of the embodiments of the present invention may
beneficially incorporate a location detection means that is capable
of providing for accurate positioning and placement of the device
by sensing or otherwise allowing the detection of the location of
the device within the anatomy. More specifically, the location
detection means may allow the detection of the location of the
device in order to ensure the proper placement of the components of
the device within the annulus, nucleus, and/or the interface
between the annulus and nucleus. Additionally, the location
detection means may also serve as a locking member to maintain a
position of at least a portion of the device with respect to the
body.
Various methods disclosed herein could be used for such purposes.
One embodiment would include the use of an expanding balloon or an
articulating wing or finger to locate the interface between the
nucleus and annulus, and assure proper placement of the closure or
treatment device. By way of example, the delivery instrument could
have an expandable or reconfigurable member (e.g. flange, balloon,
anchor, finger, foot plate, etc.) that can be used to help locate
the transition between the annulus and nucleus or other adjacent
tissues. Such expandable or reconfigurable members could help
provide an indication of proper location for device placement as
well as help to create a physical space into which a device can be
implanted. The system could be advanced into the appropriate tissue
and then the expandable or reconfigurable element could be
activated, the device could be withdrawn, advanced, or otherwise
manipulated until an indicator provides a signal that the device is
at the desirable location. Concepts of this approach could employ
"tactile feel" as one indicator, to sense when a delivery system is
at the appropriate location. Similarly, sensors may be utilized at
or near the distal end of the device to confirm placement, such as
an optical sensor or pressure sensor that may be exposed to tissue
during placement of the device, and enable confirmation of accurate
placement of the device.
It is recognized that such an expandable or reconfigurable member
may also beneficially serve to stabilize the disc, and or the
components of the invention during and after placement of the
device. Additionally, other stabilizing components may be utilized
to achieve proper placement of the device, such as a sliding ring,
flange, or other component that may be delivered following the
insertion of a delivery tube or sheath, and placed against the
target site, or the surrounding tissues to lend stability to the
device. As can be seen with reference to FIGS. 36-46, and to be
discussed in further detail below, the expandable member may be
expanded against the annulus interior wall, thereby preventing the
retraction of the positioning device from the nucleus, and
stabilizing the positioning member. Optionally, a slidable flange
may be advanced along the body of the positioning device in order
to apply securing pressure against the exterior of the annulus, or
other tissue, thereby maintaining the accurate placement of the
positioning device. The flange may be advanced by external
application of force, or alternatively, may be advanced by
operation of an advancing mechanism, such that the slidable flange
is directed towards the distal end of the positioning device.
In another embodiment of a location detection means, a cannula or
access sheath may be provided having a separate pathway (e.g. a
lumen) for providing a location probe. The separate pathway may
have an exit port located at or near the distal end of the delivery
system. A flexible or reconfigurable member may be extended, either
through the device, or from the device, and allow the surgeon to
gauge the nature of the tissue, such as through tactile feel. A
member being inserted into nucleus pulposus material would relay
tactile information that the tissue is soft, as it would easily
yield to advancement of the probe. In contrast, the tough fibrous
annulus material would provide greater resistance to the
advancement of the probe, affording similar confirmation of
placement of the device.
In another embodiment, the location detection means may rely on
calibrated insertable components, such as needles, delivery
sheaths, or cannulas, which may be provided having graduated
markings to indicate depth of penetration, and allow proper
placement of the repairing components of the device.
It is also recognized that the use of markers or bands (e.g.
radiographic markers, visual markers, etc.) may provide location
information for any of the described embodiments, such as through
the use of radiographic techniques (e.g. MRI, X-ray, etc.), and
further aid in ensuring the proper placement of the device of the
present invention.
Thus since the invention disclosed herein may be embodied in other
specific forms without departing from the spirit or general
characteristics thereof, some of which forms have been indicated,
the embodiments described herein are to be considered in all
respects illustrative and not restrictive, by applying current or
future knowledge. The scope of the invention is to be indicated by
the appended claims, rather than by the foregoing description, and
all changes which come within the meaning and range of equivalency
of the claims are intended to be embraced therein.
TABLE-US-00001 TABLE 1 Examples Of Suitable Materials Aliphatic
polyesters Bioglass Cellulose Chitin Collagen Types 1 to 20 Native
fibrous Soluble Reconstituted fibrous Recombinant derived
Copolymers of glycolide Copolymers of lactide Elastin Fibrin
Glycolide/l-lactide copolymers (PGA/PLLA) Glycolide/trimethylene
carbonate copolymers (PGA/TMC) Hydrogel
Lactide/tetramethylglycolide copolymers Lactide/trimethylene
carbonate copolymers Lactide/.epsilon.-caprolactone copolymers
Lactide/.sigma.-valerolactone copolymers L-lactide/dl-lactide
copolymers Methyl methacrylate-N-vinyl pyrrolidone copolymers
Modified proteins Nylon-2 PHBA/.gamma.-hydroxyvalerate copolymers
(PHBA/HVA) PLA/polyethylene oxide copolymers PLA-polyethylene oxide
(PELA) Poly (amino acids) Poly (trimethylene carbonates) Poly
hydroxyalkanoate polymers (PHA) Poly(alklyene oxalates)
Poly(butylene diglycolate) Poly(hydroxy butyrate) (PHB)
Poly(n-vinyl pyrrolidone) Poly(ortho esters)
Polyalkyl-2-cyanoacrylates Polyanhydrides Polycyanoacrylates
Polydepsipeptides Polydihydropyrans Poly-dl-lactide (PDLLA)
Polyesteramides Polyesters of oxalic acid Polyethylene Glycol
Polyethylene Oxide Polyglycan Esters Poly(Glycerol Sebacate)
Polyglycolide (PGA) Polyiminocarbonates Polylactides (PLA)
Poly-l-lactide (PLLA) Polyorthoesters Poly-p-dioxanone (PDO)
Polypeptides Polyphosphazenes Polysaccharides Polyurethanes (PU)
Polyvinyl alcohol (PVA) Poly-.beta.-hydroxypropionate (PHPA)
Poly-.beta.-hydroxybutyrate (PBA) Poly-.sigma.-valerolactone
Poly-.beta.-alkanoic acids Poly-.beta.-malic acid (PMLA)
Poly-.epsilon.-caprolactone (PCL) Pseudo-Poly(Amino Acids) Starch
Trimethylene carbonate (TMC) Tyrosine based polymers Alginate Bone
allograft or autograft Bone Chips Calcium Calcium Phosphate Calcium
Sulfate Ceramics Chitosan Cyanoacrylate Collagen Dacron
Demineralized bone Elastin Fibrin Gelatin Glass Gold
Glycosaminoglycans Hydrogels Hydroxy apatite Hydroxyethyl
methacrylate Hyaluronic Acid Liposomes Mesenchymal cells Nitinol
Osteoblasts Oxidized regenerated cellulose Phosphate glasses
Polyethylene glycol Polyester Polysaccharides Polyvinyl alcohol
Platelets, blood cells Radiopacifiers Salts Silicone Silk Steel
(e.g. Stainless Steel) Synthetic polymers Thrombin Titanium
Tricalcium phosphate
TABLE-US-00002 TABLE 2 Examples of Biologically Active Agents
Adenovirus with or without genetic material Alcohol Amino Acids
L-Arginine Angiogenic agents Angiotensin Converting Enzyme
Inhibitors (ACE inhibitors) Angiotensin II antagonists
Anti-angiogenic agents Antiarrhythmics Amiodarone Lidocaine Sotalol
Procainamide Diltiazem Anti-bacterial agents Antibiotics
Erythromycin Penicillin Imipenem Zosyn Cipro Flagyl Vancomycin
Anti-coagulants Heparin Lovenox Anti-Fungals Anti-growth factors
Anti-inflammatory agents Dexamethasone Prednisone Aspirin
Hydrocortisone Antioxidants Anti-platelet agents Forskolin GP
IIb-IIIa inhibitors eptifibatide Anti-proliferation agents Rho
Kinase Inhibitors (+)-trans-4-(1-aminoethyl)-1-(4-pyridylcarbamoyl)
cyclohexane Anti-rejection agents Anti-restenosis agents Adenosine
A.sub.2A receptor agonists Rapamycin Antisense Anti-thrombogenic
agents Argatroban Fondaparinux Hirudin GP IIb/IIIa inhibitors
Anti-TNF Anti-viral drugs Arteriogenesis agents acidic fibroblast
growth factor (aFGF) angiogenin angiotropin basic fibroblast growth
factor (bFGF) Bone morphogenic proteins (BMP) epidermal growth
factor (EGF) fibrin granulocyte-macrophage colony stimulating
factor (GM-CSF) hepatocyte growth factor (HGF) HIF-1 Indian
hedgehog (Inh) insulin growth factor-1 (IGF-1) interleukin-8 (IL-8)
MAC-1 nicotinamide platelet-derived endothelial cell growth factor
(PD-ECGF) platelet-derived growth factor (PDGF) transforming growth
factors alpha & beta (TGF-.alpha., TGF-beta.) tumor necrosis
factor alpha (TNF-.alpha.) vascular endothelial growth factor
(VEGF) vascular permeability factor (VPF) Bacteria Beta blocker
Blood clotting factor Bone morphogenic proteins (BMP) Calcium
channel blockers Carcinogens Cells Stem cells Bone Marrow Blood
cells Fat Cells Muscle Cells Umbilical cord cells Chemotherapeutic
agents 5-FU Ceramide Cisplatin Cyclophosphamide Doxorubicin
Flutamide Imatinib Levamisole Methotrexate Mitomycin Oxaliplatin
Paclitaxel Tamoxifen Taxol Topotecan Vinblastine Cholesterol
reducers Chondroitin Clopidegrel (e.g., plavix) Collagen Inhibitors
Colony stimulating factors Coumadin Cytokines prostaglandins Dentin
Etretinate Genetic material Glucosamine Glycosaminoglycans GP
IIb/IIIa inhibitors L-703,081 Granulocyte-macrophage colony
stimulating factor (GM-CSF) Growth factor antagonists or inhibitors
Growth factors Autologous Growth Factors Bovine derived cytokines
Cartilage Derived Growth Factor (CDGF) Endothelial Cell Growth
Factor (ECGF) Epidermal growth factor (EGF) Fibroblast Growth
Factors (FGF) Hepatocyte growth factor (HGF) Insulin-like Growth
Factors (e.g. IGF-I) Nerve growth factor (NGF) Platelet Derived
Growth Factor (PDGF) Recombinant NGF (rhNGF) Tissue necrosis factor
(TNF) Tissue derived cytokines Transforming growth factors alpha
(TGF-alpha) Transforming growth factors beta (TGF-beta) Vascular
Endothelial Growth Factor (VEGF) Vascular permeability factor (VPF)
Acidic fibroblast growth factor (aFGF) Basic fibroblast growth
factor (bFGF) Epidermal growth factor (EGF) Hepatocyte growth
factor (HGF) Insulin growth factor-1 (IGF-1) Platelet-derived
endothelial cell growth factor (PD-ECGF) Tumor necrosis factor
alpha (TNF-.alpha.) Growth hormones Heparin sulfate proteoglycan
HMC-CoA reductase inhibitors (statins) Hormones Erythropoietin
Immoxidal Immunosuppressant agents Immune modulator agents
Inflammatory mediator Insulin Interleukins Interlukins Interlukin-8
(IL-8) Lipid lowering agents Lipo-proteins Low-molecular weight
heparin Lymphocites Lysine MAC-1 Methylation inhibitors Morphogens
Bone morphogenic proteins (BMPs) Nitric oxide (NO) Nucleotides
Peptides Polyphenol PR39 Proteins Prostaglandins Proteoglycans
Perlecan Radioactive materials Iodine - 125 Iodine - 131 Iridium -
192 Palladium 103 Radio-pharmaceuticals Secondary Messengers
Ceramide Signal Transduction Factors Signaling Proteins
Somatomedins Statins Stem Cells Steroids Sulfonyl Thrombin Thrombin
inhibitor Thrombolytics Ticlid Tumor necrosis factor Tyrosine
kinase Inhibitors ST638 AG-17 Vasodilator Histamine Forskolin
Nitroglycerin Vitamins E C Yeast Ziyphi fructus
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